Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07101432
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given by infusion
  • Cyclophosphamide — DRUG
    Given by infusion

Study Details

To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2/interleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR/IL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.

Key Dates

Start date
Nov 4, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 ESC Safety Lead-in - TROP2 CAR/IL-15 TGFBR2 KO NK Cells
    Participants will receive treatment on an outpatient basis
  • Experimental: Phase 1 ESC/EXP - TROP2 CAR/IL-15 TGFBR2 KO NK Cells + RT
    Participants will receive treatment on an outpatient basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Gohar Manzar, MD
[email protected]
713-792-4503
Gohar Manzar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

Related Studies